DIGITAL TENS DUAL CHANNEL

GUDID 04716770925806

DIGITAL TENS DUAL CHANNEL

BESMED HEALTH BUSINESS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID04716770925806
NIH Device Record Key623a6306-1df9-4ffa-8b9a-56cef6cd65c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIGITAL TENS DUAL CHANNEL
Version Model NumberBE-92580
Company DUNS658023775
Company NameBESMED HEALTH BUSINESS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770925806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2017-12-15

On-Brand Devices [DIGITAL TENS DUAL CHANNEL]

04716770926605BE-92660
04716770925806DIGITAL TENS DUAL CHANNEL
04716770005805BE-580

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.